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Recall Observatory FDA recall evidence

Device product

Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili

Z-2814-2015

August 24, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc
Event
Event 72044
Status
Terminated
Classification
Class II
Quantity
1213 cartridges
Official record key
device-enforcement:Z-2814-2015

Official wording

Reason: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

Code information: Serial Numbers: 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Canada, Albania, Austria, Australia, Bosnia Herzeg., Bangladesh, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Denmark, Estonia, Spain, Finland, France, Great Britain, Georgia, Greece, Croatia, Hungary, Ireland, India, Italy, Lithuania, Luxembourg, Latvia, Macedonia, Malaysia, Netherlands, Norway, New Zealand, Poland, Portugal, Paraguay, Romania, Sweden, Singapore, Slovenia, Slovakia, Turkey, Taiwan, South Africa, Unit.Arab Emirates

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results